Fassier-Duval Telescopic Im System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref FD-064(SPL)-SSModel NAIL IMPLANT

by Orthopediatrics Canada ULC

Identity

Trade Name: The Fassier-Duval Telescopic IM System EUDAMED
FASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
Generic Name: Arthrodesis intramedullary nail, non-distracting FDA UDI
Device Name: Short Proximal Long Distal Nail Assy Ø6.4mm x 412mm FDA UDI
Model / Reference: FD-064(SPL)-SS EUDAMEDFDA UDI
NAIL IMPLANT EUDAMED
Description: Short Proximal Long Distal Nail Assy Ø6.4mm x 412mm FDA UDI

Identifiers

Catalog Number: FD-064(SPL)-SS FDA UDI
Primary DI / UDI-DI: 07540194000521 EUDAMEDFDA UDI
Basic UDI-DI: 7540194FD-NAILSM7 EUDAMED
510(k) Number: K020885 FDA UDI
K041393 FDA UDI
FDA Product Code: HSB FDA UDI
EMDN Code: P09120201 INTRAMEDULLARY NAILS EUDAMED
GMDN Term: Arthrodesis intramedullary nail, non-distracting FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Market of Registration: Sweden EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 6.4 Millimeter FDA UDI
Length — 412 Millimeter FDA UDI

Category: Arthrodesis intramedullary nail, non-distracting

Fassier-Duval Telescopic Im System by Orthopediatrics Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
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Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Canada ULC

Sources (2)

FDA UDI 790d37a0-beb3-4b06-aa52-fb2325851fc1 38 fields · synced Jun 19, 2026
EUDAMED 8415b6fd-09b0-48c0-9f1a-688c5f423205 61 fields · synced Jun 19, 2026

Fassier-Duval Telescopic Im System

Identity

Identifiers

Classification

Clinical & Handling

Dimensions & Sizes

Similar devices

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

Manufacturer

Sources (2)